MAUDE Adverse Event Report: GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD HAIOU AUTO DISPOSABLE SYRINGE; SYRINGE, ANTISTICK

Lot Number 20JC2

Device Problems Break (1069); Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

Good morning (b)(6) staff, we had two reports of malfunctioning syringe/needles used for covid vaccine that we reported via our (b)(6).I think these were the same brand as for the warning sent out in (b)(6) from (b)(6) which i had forwarded to our staff, but unfortunately, looks like we got them in our system anyway.We have submitted two jpsrs (number (b)(4)), one for the hub that broke off in the veterans arm and one for the needle that came through the side of the syringe.The video is representative of the syringe involved in this event.They are haiou brand - note that the company's website is blocked by (b)(6) computers; we had to use our personal computer to download the "haiou auto disposable syringe" infographic.Lot number of the syringe was 20jc2, same as the picture in the wrapper.We will cease use of these syringes, and sequestered what we have.Please let me know if we can provide any more information.The needle plus hub stayed in the patient's arm after full injection and removal of the syringe.The nurse was able to quickly pluck it out and the patient did not know anything was amiss.The nurse noted that there was no residual liquid (vaccine) in the hub, on the patient's arm, and there was no blood either.It was felt that the patient received the whole dose.Here is the actual report sent by our nurse, not sure if i had included that: veteran was in covid-19 vaccine clinic.Veteran received vaccine and the hub and needle stayed in veteran's arm.The vaccinator removed it and there was no blood discharged from hub or residual vaccine.Veteran was not aware of the situation.The said syringes have not retracted in the way they were designed to and there has been concern.This is the first time one has come apart in the arm during vaccination.The pharmacy and clinic administration team have been notified and a picture of one of the other malfunctions was sent and report made.(b)(6).

• Brand Name: HAIOU AUTO DISPOSABLE SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
• MDR Report Key: 12843807
• MDR Text Key: 281110316
• Report Number: MW5105455
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 20JC2
• Patient Sequence Number: 1